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Philips
Vigilance Reporting SpecialistPhilips • New Kensington, Pennsylvania, us
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Vigilance Reporting Specialist

Vigilance Reporting Specialist

Philips • New Kensington, Pennsylvania, us
15 days ago
Job type
  • Full-time
Job description
Job Title

Vigilance Reporting Specialist

Job Description

Lead complaint operations by resolving complex issues, guiding evaluators, analyzing processes for improvement, and ensuring compliant, data-driven oversight through cross-functional leadership and team development.

Your role:

* Provides guidance on mid-complexity product issues and supports complaint evaluators and investigators by answering questions and ensuring clear communication.

* Analyzes complaint handling processes, evaluates evaluator and investigator performance, identifies bottlenecks, and recommends process improvements.

* Resolves complex complaints under broad guidelines, reviews reportability assessments, and escalates issues as needed for further determination.

* Trains and mentors new complaint operations specialists, develops training materials, and supports ongoing skill development.

* Leads complaint operations activities, including data analysis, cross-functional collaboration, and oversight of complaint screening, evaluation, and coding accuracy. Monitors team performance, supports management with operational needs, and contributes to process improvements and regulatory compliance efforts.

You're the right fit if:

* You've acquired 2+ years of experience in medical device or another regulated industry.

* Your skills include a basic understanding of corrective and preventive action, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO1497, and ISO9001.

* You have at least a bachelor's degree in biomedical engineering, science, healthcare, or in the clinical/medical field.

* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

* Learn more about our business.

* Discover our rich and exciting history.

* Learn more about our purpose.

* Learn more about our culture.

Philips Transparency Details

The pay range for this position in Pennsylvania is $92,000 to $146,000 annually.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to New Kensington, PA.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
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Vigilance Reporting Specialist • New Kensington, Pennsylvania, us

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